Building a 510(k) market-ready QMS in 90 days

Who are SimBioSys?
Chicago, IL
Company size

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SimBioSys is the developer of an innovative Class II software as medical device (SaMD) platform designed to revolutionize computational oncology.

By digitally modelling breast MRI scan data, including tumor growth and medicinal impact, SimBioSys' TumorSight platform unlocks precise, pre-simulated cancer care that saves lives.

SimBioSys needed FDA 510(k) clearance to bring TumorSight to market, followed by ISO 13485 and IEC 62304 accreditation and MDSAP compliance.

The challenge

As a start-up, SimBioSys had no internal regulatory expertise or a functioning quality management system. Besides a handful of documents in a OneDrive folder, the company lacked a real quality structure or documented basics like a quality manual.

When VP of Regulatory & Quality Hilary Baldwin joined the team, she brought some valuable eQMS experience with her and recognised the powerful business benefits of going straight to a digital eQMS and sidestepping paper altogether.

We needed a quality system and a centralized location for everyone to understand.

— Hilary Baldwin, VP of Regulatory & Quality, SimBioSys

Hilary's first task was therefore to position the company for success by implementing a suitable, trusted eQMS platform to build the company's digitized quality system into.

Along with VP of Software & IT Michael Hallock, she began the search.

The solution

Hilary had implemented MasterControl in a previous role and hadn't enjoyed the experience.

It was critical she found a system that was easy to use, could be quickly validated, and would accelerate SimBioSys' journey to market.

A colleague from a previous role, Becki, had implemented Qualio at her own company Synthego and passed their first ever FDA submission with flying colors.

After a glowing endorsement of Qualio and its ease of use, Hilary wanted to try the system herself.

This is our first FDA submission and the last thing I wanted was a bunch of additional questions.

I wanted the team to see the FDA asking meaningful things about our technology.

If I could remove one more layer of questions about the formatting or the clarity of our QMS, that's what I wanted to do.

And that's what's happening with Qualio.

— Hilary Baldwin, VP of Regulatory & Quality, SimBioSys
The results

The SimBioSys team needed an eQMS which was quick and easy to implement and start using.

Qualio delivered that potential, with the first users logged in within a month and a complete QMS built into the software in just 90 days.

Everyone in the team, from staff to contractors and consultants, now use Qualio for document access and training activities, from HR and HIPPA to privacy, day-to-day SOPs and ISO 13485 readiness.

Since SimBioSys are pursuing multiple standards simultaneously, Qualio's document functionality became invaluable, connecting key documents with standard-specific tags and smart linking for a holistic, market-ready information library. 

Information can be quickly and easily shared with third parties too, with Hilary noticing a 'collaboration factor' from using Qualio that simply wasn't possible with a paper-based QMS.

Hilary could also lean on the Qualio+ offering for extra quality and regulatory support, tapping the expertise of Sumatha to help the company's market preparations.

With faster, sharper processes and complete visibility of their quality landscape, Hilary, Michael and the team saw instant payback from their Qualio investment, with SimBioSys securing a successful 510(k) clearance for TumorSight in December 2023.

And clunky, Excel-based medical device quality processes are now a thing of the past:

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